BIOTECHNOLOGY 2013 - Mobile Medical Applications and Devices: Trends and Regulations in US & Globally

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Category BIOTECHNOLOGY 2013

Deadline: May 23, 2013 | Date: May 23, 2013

Venue/Country: Online, U.S.A

Updated: 2013-05-03 17:49:55 (GMT+9)

Call For Papers - CFP

Mobile medical applications and devices is a growing field globally. New rules and regulatory efforts are coming to ensure that the related medical devices will not pose high risks for patient safety and promote innovations.

This webinar will provide past and expected regulations and discuss their effects on the use of mobile medical application for devices. We'll elucidate the current policies, predict coming regulations and discuss how mobile Health (m-Health) industry will be affected. We will explore the current emerging m-Health landscape and technology trends in US and globally.

All groups who have responsibility or need to understand the new technologies and regulations of mobile medical applications and biomedical software( devices and smartphones) should attend.

Description of the topic :

Mobile-Health is the field of using mobile devices to provide services and support for healthcare and public health. It’s a fast growing field globally that targets doctors, patients, consumers, managers and IT groups among others. The trends for this field are showing a lot of investments and high revenues for the coming years. Several government agencies in US (FDA, FTC, FCC, ONC) and worldwide are preparing guidances and regulations to protect patient safety and privacy of health information. In addition there are other standards development organizations who try to harmonize efforts globally to propose mHealth standards for new mobile health systems. The topic and the field of Mobile Health and mobile medical applications is multidisciplinary since multiple stakeholders are involved and have a lot of interests.

Areas Covered in the Session:

? Overview of Health IT and Mobile health industry

? Basic of mobile applications for health

? Medical devices related to mobile health

? Draft guidances in mobile medical apps(FDA 2011-2012)

? FDA Safety & Innovation Act, (ONC, FCC, FDA) and Mobile Health

? Patient and Consumer health information and security

? Coming FDA final guidelines and DHHS actions

? Mobile health standards

? Mobile Health globally(WHO, EU)

? Future of Mobile Health industry and workforce

Who will benefit: (Titles)

? Management

? Health IT Managers - Analysts

? Research and Development

? Regulatory Affairs personnel

? Quality assurance/quality control personnel

? Auditors and inspectors

? Entrepreneurs ? Investors

About Speaker

"Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, is Biomedical/Health Information Advisor, Author & Strategist. He is certified on EHR/PHR, Business Architecture, Clinical Trials, Biotech/Drug Development, and trained in FDA laws and regulations for different medical products and population health (devices, foods, drugs). He has a strong academic background in computational sciences, simulations and informatics field. www.linkedin.com/in/kostamakrodimitris

? He is also involved as is Executive Director of the Global Bio Health Tech Center (GBHTC)

? Medical Devices Committee Member, Writer at The Food and Drug Law Institute,

? Advisor, Member at DHHS/ONC-HIT Standards & Interoperability, Health Information Management Systems Society, Health Level 7

? Health/Biotech/IT Policy trainer & instructor at ComplianceOnline, Compliance2go & Global Compliance Panel

? Nifty-Fifty Nominee nationwide, Speaker, Volunteer at USA Science-Engineering Festival

His multifaceted area of work is in biomedical/health technology, architecture, policy, standards and decision making.

? In academia (Johns Hopkins, University of Virginia, National Technical University of Athens), Kosta researched and published articles in archival journals concerning biomedical applications, multiscale simulations and bio-chem-informatics.

? In industry (FannieMae, Sysco/Sentrana, MakronanoKosmos, Syneren, Cal2Cal) Kosta innovated decision systems, managed analytics projects, cofounded eHealth business, consulted business development and provided policy analysis.

? In government (US-FDA/DHHS Commissioner's Fellow), Kosta trained and worked in regulatory science, enterprise architecture, standards, policy and decision support in public health and health IT(FHA/FHIMS, ONC S&I). He served as Program Manager, for Maryland BioTechnology Center, Dept of Business and Economic Development."

Speaker : Kosta Makrodimitris

Product ID : F62320

Schedule Date :

Thursday, May 23, 2013

duration : 01:00 to 02:30 PM EDT

https://compliance2go.com/index.php?option=com_training&speakerkey=59&productKey=238